Slow-Release Antibiotic Middle Ear Implant for Glue Ear Treatment

Lead Research Organisation: University of Nottingham
Department Name: Div of Otorhinolaryngology

Abstract

Glue ear is a common cause of deafness in childhood, affecting up to 75% of children. It is caused by persistent bacterial infection (biofilm) that is impossible to cure with traditional antibiotic treatment, but can be resolved with a prolonged course of high dose antibiotics given directly to the affected area. The current treatment of severe persistent glue ear consists of grommet (ventilation tube) insertion, but although this is the commonest surgical procedure in children, it only removes the glue fluid and does not address the underlying problem of bacterial biofilm infection. Therefore, a quarter of children require further grommet insertion within 2 years of initial surgery, and management of glue ear and its long-term complications presents a significant problem and workload to the clinician.
We plan to investigate a novel alternative strategy for glue ear treatment, by developing a slow-release antibiotic implant that can be inserted into the middle ear to release antibiotics at a high dose over a prolonged period of time to eradicate infection. This project in a laboratory setting will develop the slow-release antibiotic implant and test its effectiveness against bacterial biofilm infection.

Technical Summary

BACKGROUND: Otitis media with effusion (OME, glue ear) is a common cause of hearing loss in childhood, affecting up to 75% of children, and treatment with grommets (ventilation tube) insertion is the commonest indication for surgery in children. OME is thought to be caused by bacterial infection, with bacteria persisting in the middle ear as biofilms (adherent three-dimensional structured communities of bacteria growing in a self-produced extracellular matrix). Such bacteria are recalcitrant (resistant) to conventional antibiotic treatments, accounting for the failure of oral antibiotics to confer a lasting benefit in children with OME. However, whilst grommet insertion removes glue (a product of increased mucous production by the middle ear mucosa irritated by bacterial presence), it does not address the underlying problem of bacterial infection. Therefore, a quarter of children require further grommet insertion within 2 years of initial surgery.
AIM: We plan to investigate a novel alternative strategy for glue ear treatment, by developing a slow-release antibiotic implant that can be inserted into the middle ear to release antibiotics at a high dose over a prolonged period of time to eradicate infection.
METHODS: This laboratory project will optimise the formulation for surgical handling. Antibiotic release will be assessed using serial dilution and High Performance Liquid Chromatography. Microbiological effectiveness will be assessed using minimum inhibitory concentration agar plate assay, and biofilms cultured on silicone tubing will be used to assess effectiveness of the antibiotic implant against established biofilms in a novel in vitro model
POTENTIAL APPLICATION: If successful, we would expect patients to benefit from this research within less than 5 years. The antibiotic implant may reduce recurrence of OME and associated long-term complications including hearing loss, and may replace the need for grommet insertion with a simpler procedure involving just the placement of the antibiotic implant. As the project uses existing antibiotics and slow-release techniques for a new application, better treatment of glue ear could be developed at very little cost. Following laboratory research, a clinical trial would be planned in association with the National Biomedical Unit in Hearing.

Publications

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